Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma (Asthma PBM)
研究概览
详细说明
Asthma is a chronic inflammatory disease characterized by airway hyperresponsiveness, persistent inflammation, airflow limitation, and structural airway remodeling. Pediatric asthma remains a major public health concern due to its impact on lung development, exercise tolerance, quality of life, and healthcare utilization. Despite advances in pharmacological therapies, many children continue to experience symptoms, exacerbations, and functional limitations, highlighting the need for complementary therapeutic strategies.
Photobiomodulation therapy (PBMT) has emerged as a promising non-invasive intervention capable of modulating biological processes through light energy absorption by cellular photoreceptors. By stimulating mitochondrial activity and enhancing ATP production, PBMT may reduce inflammatory responses, improve tissue repair, and optimize microcirculatory function without inducing thermal damage. Experimental studies have demonstrated anti-inflammatory effects associated with reductions in pro-inflammatory cytokines and oxidative stress markers.
This randomized clinical trial aims to investigate the chronic effects of an LED vest-based photobiomodulation intervention on functional capacity, inflammatory markers, and pulmonary outcomes in children aged 6-17 years diagnosed with mild to moderate asthma. Participants will be randomly assigned to either an intervention group receiving active LED treatment or a control group receiving sham treatment through an inactive vest. Clinical and functional assessments will include spirometry, Asthma Control Test (ACT), GINA assessment, and the Incremental Step Test (IST) to evaluate exercise tolerance. Additional physiological parameters may be analyzed to investigate underlying mechanisms associated with treatment response.
The findings of this study may contribute to the development of innovative, accessible, and clinically applicable therapeutic strategies for pediatric asthma management.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Luciana M Sampaio, Dra
- 电话号码:+55011996002075
- 邮箱:lucianamalosa@gmail.com
研究联系人备份
- 姓名:Emilia R Nascimento
- 电话号码:+55019997924782
- 邮箱:ernemilia@gmail.com
学习地点
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São Paulo
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São Paulo、São Paulo、巴西、01525000
- Uninove
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接触:
- Luciana M Sampaio, Dra
- 电话号码:+55011996002075
- 邮箱:lucianamalosa@gmail.com
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Photobiomodulation and exercise
20 minutes using PTBM after 30 minutes making aerobic exercise
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1. Duration: 20 minutes per session. Intervention group: vest with active LEDs (according to the table below). Control group (placebo): identical vest without light emission. Application site: anterior and posterior thoracic regions, covering the pulmonary fields and dorsal musculature. Frequency: twice weekly, with a minimum interval of 48 hours between sessions. Conditions:*application performed at rest, with the child comfortably seated or lying down, under the supervision of the principal investigator. |
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假比较器:Exercise
30 minutes making aerobic exercise
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Supervised Physical Training: The physical exercise protocol will be initiated immediately after vest application, aiming to improve functional capacity and respiratory symptom control, with safety and continuous monitoring. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional exercise capacity
大体时间:From enrollment to the end of treatment at 8 week
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Oxugen consumption measured during cardiopulmonary testing
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From enrollment to the end of treatment at 8 week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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FVC
大体时间:From enrollment to the end of treatment at 8 week
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lung function- forced vital capacity
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From enrollment to the end of treatment at 8 week
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FEV1
大体时间:From enrollment to the end of treatment at 8 week
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lung function- expiratory volume in 1 second
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From enrollment to the end of treatment at 8 week
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Global Initiative for Asthma
大体时间:From enrollment to the end of treatment at 8 week
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score
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From enrollment to the end of treatment at 8 week
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合作者和调查者
调查人员
- 首席研究员:Luciana M Sampaio, Dra、University of Nove de Julho
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Asthma and photobiomodulation
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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